Use of Anti-CD146 Autoantibodies for the Diagnosis of Pulmonary Diseases Secondary to Occupational Exposure to Silica

NCT07376291 | Not Yet Recruiting

• 1 other identifier: 2024-A02509-38
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, multicenter study aims to evaluate the relevance of anti-CD146 autoantibodies (AACD146) as biological markers for the early diagnosis of pulmonary diseases related to occupational exposure to silica. Silica exposure is a recognized risk factor for fibrotic, inflammatory, and cancerous respiratory diseases. Currently, no specific biological marker exists. The hypothesis is that AACD146 reflects early effects of silica exposure. The study will include 110 participants divided into two groups (exposed vs. non-exposed) and will compare AACD146 prevalence according to exposure level and the presence of respiratory diseases.

Conditions

Pulmonary Diseases; Exposure Occupational

Keywords

silica; Exposure occupational; Pulmonary diseases

Outcome Measures

Primary Outcomes (1)

• Prevalence ratio of AACD146 between the exposed and non-exposed groups.

  At enrollment

Secondary Outcomes (5)

• AACD146 prevalence in patients with interstitial or neoplastic lung disease.

  At enrollment

• AACD146 Prevalence by type of interstitial lung disease

  At enrollment

• AACD146 Prevalence by type of histological type of lung cancer.

  At enrollment

• Correlation between AACD146 and exposure duration and dose to silica

  At enrollment

• Correlation between AACD146 and soluble CD146

  At enrollment

Study Arms (2)

Non-exposed

OTHER

Subject with low exposure to silica \<0.1 mg/m3 in the course of their professional activity

Other: Respiratory function testing; Biological: blood sampling

Exposed

OTHER

Subject with moderate or high exposure to silica (\>= 0.1 mg/m3) in the course of their professional activity

Other: Respiratory function testing; Biological: blood sampling; Radiation: CT scan

Interventions

blood sampling BIOLOGICAL

25mL peripheral blood will be collected

Exposed; Non-exposed

CT scan RADIATION

Non-injected thoracic CT scan

Exposed

Respiratory function testing OTHER

Spirometry, plethysmography, FeNO test

Exposed; Non-exposed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject, male or female, aged 18 or over
• Subject with low exposure to silica \<0.1 mg/m3 in the course of their professional activity, quantified during an occupational health consultation using an employment-exposure matrix
• Subjects capable of consenting to participate in the study by signing a written informed consent form
• Subjects who are beneficiaries of or affiliated with a social security system
• Subject, male or female, aged 18 or over
• Subject with moderate or high exposure to silica (\>= 0.1 mg/m3) in the course of their professional activity, quantified during an occupational health consultation using an employment-exposure matrix.
• Subjects capable of consenting to participate in the study by signing a written informed consent form
• Subjects who are beneficiaries of or affiliated with a social security system

You may not qualify if:

• Minor subject
• Subject refusing to undergo the examinations required by the protocol
• Contraindications to respiratory function tests: Recent eye or throat surgery, recent myocardial infarction or pulmonary embolism, poorly controlled high blood pressure, recent pneumothorax.
• Pregnant or breastfeeding women, patients under guardianship or curatorship, deprived of liberty

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Lung Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01